FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using.
Keep out of the reach of children.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For once daily, self-administered, systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F-) during the period of tooth development results in a significant decrease in the incidence of dental caries. Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F-.
History
There is currently no drug history available for this drug.
Other Information
Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops are dye free. Each 4 drop dose of 2.21 mg (full strength) contains 1.0 mg of the fluoride ion (F-) from 2.21 mg sodium fluoride (NaF).
Each 4 drops for oral administration contains sodium fluoride equivalent to 1.0 mg of the fluoride ion and the following inactive ingredients: Purified Water USP, methylparaben and propylparaben.
Sources
Flura-drops Manufacturers
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Kirkman Group, Inc.
Flura-drops | Kirkman Group, Inc.
Follow the directions for using this medication provided by your doctor. This medicine may be given undiluted or mixed with a non-dairy liquid.
Daily Pediatric Dose Fluoride Content of
Drinking Water: Birth to
6 mos. 6 mos. to
Age 3 Age 3
to 6 Age 6
to 16 Less than 0.3 ppm 0 1 drop 2 drops 4 drops 0.3 to 0.6 ppm 0 0 1 drop 2 drops Greater than 0.6 ppm 0 0 0 0 May be mixed with water or fruit juice; do not mix with milk or dairy products.
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